Assent Form Guidelines by yoursovain

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									                                          ASSENT

What is assent?
Assent is defined as an “agreement by an individual not competent to give legally valid
informed consent (e.g., a child or cognitively impaired person) to participate in research.”
IRB Guidebook: http://www.hhs.gov/ohrp/irb/irb_glossary.htm


When is assent generally required?
  Subjects are minors between the ages of 7 and 17. Children below the age of 7 are
   generally not asked to provide assent.
  Subjects 18 or older are intellectually or emotionally impaired and not legally competent
   to give their informed consent.

Is a separate assent form needed?
   Minor subjects who are able to read and understand the informed consent document
    (parent's permission form) may provide assent on that form with a separate signature
    line.
   Minor subjects (aged 7 or older) who are too young or intellectually immature to read
    and understand the parent's permission form should be given the opportunity to provide
    written assent on a simplified assent form.
   Adult subjects (18 or older) who are not legally competent to give their informed
    consent should be given the opportunity to provide written assent on a simplified assent
    form.

What should be included in the assent form?
  Study Title
  Study Purpose-Provide a brief explanation of the purpose of the study.
  Procedures-Describe what the subject is being asked to do.
  Withdrawal privilege- Describe how a subject can stop participation later even if he/she
   agrees to start.
  Voluntary participation- Include a statement that the subject does not have to
   participate.
  Confidentiality-Indicate that the experimenter will not tell anyone (parents, teachers)
   what the subject says or does in the study.
  Signature lines-Include a signature line for the subject and for the investigator. Be sure
   to include a date line as well.

 Language Level
  Write the form using language that is appropriate for the age level and mental capacity
   of subjects.
                                 SAMPLE ASSENT FORM

EXERCISE AND NUTRITION STUDY

My name is Susan Researcher. I work at Old Dominion University.

I am asking you to take part in a research study because I am trying to learn more about
exercise and nutrition. I want to learn about the types of exercises kids your age do and
what kinds of food they eat.

If you agree, you will be asked to complete a survey. You will be asked how often you
exercise and what kind of exercises you do. You will also be asked the kind of foods you
eat. You will be asked to give us your height and weight. Answering these questions will
take about 20 minutes. You do not have to put your name on the survey.

You do not have to be in this study. No one will be mad at you if you decide not to do this
study. Even if you start, you can stop later if you want. You may ask questions about the
study.

If you decide to be in the study I will not tell anyone else what you say or do in the study.
Even if your parents or teachers ask, I will not tell them about what you say or do in the
study.

Signing here means that you have read this form or have had it read to you and that you
are willing to be in this study.


Signature of subject______________________________________________________

Subject’s printed name ___________________________________________________

Signature of investigator__________________________________________________

Date___________________________

								
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